FDA-Device2021-09-08Class II
TRUMATCH CT CUT GUIDE FEM L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number: 420917
DePuy Orthopaedics, Inc.
Hazard
Software: A coding error associated with the Fast3D Segmentation software. During the scanning process the three images required of the hip, knee and ankle may not be aligned, causing the anatomic landmark locations to potentially result in limb malalignment.
Sold states
Distribution to US states of CA, CO, FL, IL, IN, NY, MI, MN, TX, and WA, Poland and UK.
Affected count
1 cs (1/cs)
Manufactured in
700 Orthopaedic Dr, N/A, Warsaw, IN, United States
Products
TRUMATCH CT CUT GUIDE FEM L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number: 420917
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2400-2021Don't want to check this manually?
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